Bristol Myers Squibb New Brunswick , NJ 08903
This position is responsible for the leadership and overall management of the Reference Standard & Critical Reagent (RSCR) Operations organization for all products at BMS (pharma & biologics), ensuring compliance with cGMP requirements as part of the Analytical Science and Technology (AS&T) unit within the Global Quality Organization.
The RSCR operations group is accountable for delivering the work processes for establishing, managing, and maintaining reference standards and critical reagents, ensuring a consistent and reliable supply of these materials to the broader BMS network of testing laboratories. The operations team will work closely with analytical leads, project teams and technology staff to define and deliver scientifically sound and compliant reference standard / critical reagent storage and logistics solutions. As a member of the AS&T extended leadership team, the associate director of RSCR operations will partner with stakeholders across the organization to build robust business processes to facilitate seamless execution of program deliverables and ensure harmonization of execution across the global analytical network.
Responsible for establishing and maintaining a new global analytical business and compliance process that facilitates the seamless delivery of reference standards and critical reagents to the global BMS testing network.
Manage a team of scientists ensuring appropriate training, skills, and approaches are demonstrated, while working according to GMP requirements and Health Authority expectations.
Responsible for ensuring the continuous supply of standards and reagents to the BMS global testing network supporting on-going testing capabilities of the BMS global product landscape.
Owner of the quality systems, SOPs and technical documents associated with the reference standard and critical reagent program.
Responsible for accurate records of the current inventory and qualification status of all reference standards and critical reagents used within the BMS global network, facilitating the projection of usage and anticipates need to ensure seamless operations.
Owner of new laboratory and storage facilities for the support of reference standard and critical reagent operations.
Participates and presents in network meetings to provide support and troubleshooting for reference standard and critical reagent operations.
Ensures data integrity and scientifically sound approaches are used for data generation and management.
Specific Knowledge, Skills, Abilities, etc:
Must have industry experience with reference standards and critical reagents for both biologics and small molecule entities, or at least one, with demonstration of clear understanding of both modalities.
Must have prior experience leading a team within a GMP environment, and preferably, demonstrated the ability to establish new teams and institute a dynamic culture.
Must demonstrate teamwork, project planning, strong organizational skills, computer competency, and effective written and verbal communications within both structural and matrix organizations.
To be successful in this role, the candidate must embrace collaboration with partners, customers, and team members, while operating with integrity, as well as seeking and participating in the continuous improvement of systems and culture.
A PhD in biological sciences, chemistry, engineering or related scientific disciplines with at least ~10 years of industrial experience in drug development, quality control and/or analytical development or a MS in biological sciences, chemistry, or related scientific disciplines with at least ~15 years of industrial experiences in drug development quality control and/or analytical development. Preferably, the ideal candidate will also have project management and/or OpEx training or certification.
Physical Demands / Work Environment:
This is primarily a leadership role for commercial and clinical programs, including office work, teleconferencing, computer work, and running meetings. Including
Sitting / standing
Repetitive (Use of arms, hands, wrists)
Working in a Team
Working with/around others
This role is a manager of people.
This position will have direct reports.